Abstract:
OBJECTIVE To establish a method for determining the release rate of tulobuterol patch, evaluate the consistence of the release curve between different test methods.
METHODS Two kinds of new transdermal release test methods in China Pharmacopoeia 2015 Edition (paddle over disk method and rotating-cylinder method) were used, the concentration of each sampling point was determined by HPLC. Agilent C
18(250 mm×4.6 mm, 5 μm) column was used with the mobile phase of a mixture of acetonitrile and 0.02 mL·min
-1 phosphate buffer (pH3.0) (32:68), the flow rate was 1 mL·min
-1, the column temperature was 35℃, and the detection wavelength was 215 nm. Transdermal release behavior of tulobuterol patch in 500 mL water were investigated in 24 h, and similarity of the release curves was compared.
RESULTS The linear correlation of tulobuterol was observed in the range of 0.103-4.135 μg·mL
-1(
r=0.999 9), with a recovery rate of 99.8%(
n=9), and the sample solution was stable in 24 h. The results of the two methods were analyzed by Weibull equation, and there was no significant difference between the two methods.
CONCLUSION Paddle over disk method (method 2) and rotating-cylinder method in China Pharmacopoeia 2015 Edition can both be used to determine the release of tulobuterol transdermal patch, and the results of these two methods are identical.